"system for image-guided surgery"

The modular and adaptable hybrid-layered architecture of the image-guided surgical system addresses the limitations of existing systems by integrating robotic assistance and navigation, enhancing precision and scalability across surgical applications while reducing radiation exposure.

WO2025150057A1PCT designated stage expired Publication Date: 2025-07-17INDIAN INST OF TECH MADRAS
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Patent Information

Application Number
PCT/IN2024/052392
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-01-10
Filing Date
2024-12-18
Publication Date
2025-07-17

AI Technical Summary

Technical Problem

Existing image-guided surgical systems are limited to specific surgical procedures, are costly, complex, and expose patients and medical staff to radiation, lacking a unified and versatile workflow that ensures precision and accuracy.

Method used

A modular and adaptable hybrid-layered architecture for an image-guided surgical system integrating robotic assistance and navigation guidance, utilizing various imaging modalities, real-time feedback, and AI-generated images to enhance precision and scalability across different surgical applications.

Benefits of technology

The system provides precise and cost-effective navigation and robotic assistance, reducing radiation exposure and ensuring patient safety, with real-time feedback and adaptability to diverse surgical procedures.

✦ Generated by Eureka AI based on patent content.

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Abstract

An image-guided surgical system comprising: a surgical unit comprising one or more robotic arms (230) operating based on a pre-operative plan (102), a navigation unit (202) comprising one or more sensors (228) and an imaging device (225) for tracking movement of the one or more surgical tools in real time, a computation, processing and communication unit (CPC) (227) comprising a processor configured to analyze data received from the one or more sensors (228) and the imaging device (225) to determine a degree of compliance of the pre-operative plan (102) and / or intra-operative plan (104) and guide further the operator (212) about progress of the one or more surgical tools, a memory configured to store program modules for controlling operation of the surgical unit, the navigation unit, the data processing unit, and an interface unit comprising an output module and an input module, wherein the program modules are developed as a hybrid-layered architecture (200) and are alterable.
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Description

“SYSTEM FOR IMAGE-GUIDED SURGERY”TECHNICAE FIELD

[0001] The present invention relates to the field of image-guided surgery. More specifically, the present invention provides an image-guided surgical system for performing surgical operations using robotic assistance and / or navigation guidanceBACKGROUND OF THE INVENTION

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention or that any publication specifically or implicitly referenced is prior art.

[0003] With advancements in medical science in general and surgery in particular, surgeons are increasingly capable of performing intricate medical procedures. In the last couple of decades, image-guided surgery (IGS) has significantly advanced the realm of surgical procedures by providing real-time, precision-guided support to surgeons performing intricate tasks like instrument placement and tissue manipulation. The existing IGS systems have been contemplated to perform a specific type of surgery and not as a common platform to address all surgical applications. No wonder, the existing IGS systems often come at a considerable cost and can be operationally complex, limiting their widespread adoption, particularly in regions with limited resources. Additionally, concerns over accuracy, precision and ionising radiation exposure to both patients and medical staff remains a challenge.

[0004] While effective, traditional surgical approaches often encounter limitations related to precision and invasiveness. The advent of image-guided surgeries has significantly improved outcomes, yet a unified and versatile workflow has been elusive. Existing solutions may excel in specific aspects but lack a holistic approach to surgical interventions. The advancements in image-guided surgical procedures have enabled surgeons to perform complex surgeries; however, this has also led to an enormous amount of data being available for analysis during a surgical procedure.

[0005] Advancements in imaging technologies such as magnetic resonance imaging (MRI), computer tomography (CT) devices, nuclear magnetic resonance (NMR) equipment, positronemission tomography (PET) and ultrasound often provide a variety of 2-D and 3-D image files to the surgeons for analysis. Based on the data available, the surgeons draw a plan to execute surgery. In spite of using image-guided surgical procedures with robotic intervention and / or navigation guidance, the success of such a surgical plan for complex surgeries is subject to the expertise of the respective surgeons conducting the surgery, leading to variation in the degree of success.

[0006] In order to avoid variation in results, standard pre-planned surgical pre-operative plans have been designed so that judgemental human error during surgery can be avoided. In such cases, a programme for the respective surgery of an organ is installed in the system. The image- guided surgical system gathers data from the patient available for surgery. The collected data set is analysed by a processor, and based upon a pre-installed program, the course of surgery is finalised for the patient. Subsequently, the surgery is performed with robotic assistance, and / or navigation guidance with minimal human intervention.

[0007] Present image-guided surgical systems suffer from serious drawbacks. The foremost drawback includes the restricted ability of the existing surgical system to perform a specific type of surgery for which the surgical system is designed. For example, if a given IGS system is programmed for valve replacement surgery of a heart, then it will guide the IGS system to only that specific type of surgery. Therefore, a specific IGS system is required for performing different surgical procedures. The requirement of said specific IGS system not only makes the surgical procedures more complex but also increases the cost multiple times. Further, surgery of different intricate organs is full of uncertainties, and a single programme may not be sufficient to perform the surgery on different individuals.

[0008] In view of the above-mentioned shortcomings, there arises a need for an improved image-guided surgical system which is scalable, performs intricate surgeries of different organs, and is cost-effective.OBJECTS OF THE INVENTION

[0009] The general objective of the present invention is to provide a platform to address various image-guided surgery (IGS) applications.

[0010] Another objective of the present invention is to provide an IGS system that is simple and cost-effective for performing surgical procedures.

[0011] Yet another object of the present invention is to provide a modular and adaptable hybrid-layered architecture for surgical procedures.

[0012] Still another object of the present invention is to provide a system that reduces radiation exposure to both patients and medical staff.

[0013] Another objective of the present invention is to provide navigation guidance and robot assistance for surgical procedures which is precise and accurate.

[0014] Yet another object of the present invention is to provide the IGS system, which ensures patient safety during critical surgical procedures.

[0015] Another objective of the present invention is to provide real-time feedback to the surgeons during surgical procedures.

[0016] Another objective of the present invention is to provide an accurate and precision navigation guidance and robotic assistance.

[0017] Another objective of the present invention is to provide a platform to integrate various imaging modalities into the IGS system.

[0018] Another objective of the present invention is to provide the IGS system which is scaleable and adaptable to the integration of new technologies.SUMMARY OF THE INVENTION

[0019] The summary is provided to introduce aspects related to a device / system for image- guided surgical procedures, and the aspects are further described below in the detailed description. This summary is not intended to identify essential features of the claimed subject matter nor is it intended for use in determining or limiting the scope of the claimed subject matter.

[0020] The present invention provides an image-guided surgical (IGS) system which comprises a surgical unit comprising one or more robotic arms operating one or more surgical tools during a surgical procedure, based on a pre-operative and / or intra-operative plans and inputs of an operator. The IGS system further comprises a navigation unit comprising one or more sensors and an imaging device for tracking movement of the one or more surgical tools in real time, during the surgical procedure. The IGS system further comprises a data processingunit comprising a processor configured to analyse data received from the one or more sensors and the imaging device to determine a degree of compliance of the pre-operative plan and guide further the operator about progress of the one or more surgical tools, a memory configured to store program modules for controlling operation of the surgical unit, the navigation unit, the data processing unit, and an interface unit. The interface unit comprises an output module configured to provide data related to the movement of the one or more surgical tools to the operator, an input module configured to receive input, from the operator, in response to the data obtained from the output module. The disclosed IGS system is developed in such a way that the program modules are developed as a hybrid-layered architecture which are alterable.

[0021] According to an embodiment of the invention, the pre-operative and / or intra-operative plan is drawn based upon images acquired using the imaging device and the program modules.

[0022] According to one embodiment of the invention, the imaging device operates using one of Computed Tomography (CT) scan, Magnetic resonance imaging (MRI) scan, Ultrasound, Positron Emission Tomography (PET), X-ray scan, and 2-Dimensional C-arm / O-arm scan during the pre-operative plan and / or the surgical procedure.

[0023] According to one embodiment of the invention, the one or more sensors and the imaging device track movement of the one or more surgical tools with respect to the pre-operative plan, during the surgical procedure.

[0024] According to one embodiment of the invention, the images are used for representing 2D multiplanar reconstructed and / or 3D model of an organ to be operated during the surgical procedure.

[0025] In yet another embodiment of the invention, the input module comprises one of a touch screen and a voice recognition device.

[0026] According to one embodiment of the invention, the image-guided surgical system is configured to integrate with at least one of Augmented Reality (AR), Virtual Reality (VR), Mixed Reality (MR), and Extended reality (XR).

[0027] According to one embodiment of the invention, wherein the pre-operative and / or intraoperative plan is prepared by scanning an organ to be treated, by the imaging device using a plurality of fiducial markers.

[0028] In yet another embodiment of the invention, an ICP (Iterative Closest Point) registration is performed by the data processing unit based on images obtained from the imaging device.

[0029] According to one embodiment of the invention, the intra-operative plan can also drawn based on a plurality of artificial intelligence (Al) generated images dependent on data collected during the ICP registration.

[0030] In yet another embodiment of the invention, the pre-operative and / or intra-operative plan is alterable based upon input received from the navigation unit during the surgical procedure.

[0031] The hybrid-layered IGS system architecture offers advantages in tackling complexity, ensuring resilience, and facilitating smoother development and management. The layered architecture dissects intricate systems into distinct layers, each devoted to specific tasks. This hierarchical arrangement fosters a clear division of responsibilities. The higher layers of the architecture manage user interfaces and application logic, while the lower layers handle data management and hardware interactions. This separation promotes modularity and simplifies maintenance. An integrated architecture, on the other hand, closely interconnects and coordinates system components to form a unified whole.

[0032] Further, the modular nature of the architecture entails crafting the IGS system as an assembly of independent modules, each assigned a specific function. These modules possess well-defined interfaces, allowing for independent development, testing, and updates. This modular approach eases development, maintenance, and scalability complexities by breaking down the compound IGS system into manageable, reusable, and interchangeable components. The present hybrid-layered system architecture merges the strengths of layered, integrated, and modular approaches, creating a versatile and efficient framework that thrives in complex surgical applications. Within hybrid-layered architecture, the IGS system comprises discrete, self-contained modules. Each module takes charge of a specific function or feature, clearly separating responsibilities.

[0033] Other objects, features and advantages of the present invention will be readily appreciated as the same becomes better understood after reading the subsequent description taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0034] The accompanying drawings constitute a part of the description and are used to provide a further understanding of the present invention. Such accompanying drawings illustrate the embodiments of the present invention used to describe the principles of the present invention. The embodiments are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings in which references indicate similar elements. It should be noted that references to “an” or “one” embodiment in this invention are not necessarily to the same embodiment, and they mean at least one. In the drawings:

[0035] Fig. 1 illustrates a schematic view of workflow stages during pre-operative and intraoperative phases, in accordance with an embodiment of the present invention; and

[0036] Fig. 2 illustrates a hybrid-layered architecture of an IGS system in accordance with an embodiment of the present invention.DETAILED DESCRIPTION OF THE INVENTION

[0037] The detailed description set forth below is intended as a description of various embodiments of the present invention. It is not intended to represent the only embodiments in which the present invention may be practised. Each embodiment described in this disclosure is provided merely as an example or illustration of the present invention and should not necessarily be construed as preferred or advantageous over other embodiments. The detailed description includes specific details to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practised without these specific details.

[0038] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0039] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0040] Surgical procedures, particularly those guided by medical imaging, have witnessed a paradigm shift with the development of a comprehensive surgical workflow. The presentdisclosure addresses the critical need for enhanced precision, efficiency, and safety in image- guided surgeries. The disclosed Image-Guided Surgery (IGS) system combines the precision of navigation guidance with the agility of robotics, all within a modular and adaptable framework. The seamless integration of pre-operative planning, intra-operative guidance, and post operative assessment forms the core of the present surgical workflow.

[0041] Fig. 1 illustrates a schematic view of workflow stages 100 during a pre-operative phase 102 and an intra-operative phase 104 in accordance with the embodiment of the present invention. The pre-operative phase 102 is prepared by leveraging advanced imaging modalities, which include employing imaging devices such as Computed Tomography (CT) scan, Magnetic resonance imaging (MRI) scan, Ultrasound, Positron Emission Tomography (PET), X-ray scan, and 2-dimensional C-arm / O-arm imaging system.

[0042] During the pre-operative phase 102, a medical team prepares for surgery of a patient. In order to decide a course of action, determine surgeon needs to determine the actual condition of the organ of the body to be operated on. Depending upon the extent of damage caused to the organ, a surgeon can plan the course of action. The pre-operative phase 102 begins with acquiring pre-operative images 106, such as CT scans, providing a detailed view of the patient's spinal / organ structure. Optionally, an MRI scan is obtained and fused with the CT image for a more comprehensive understanding of the anatomy. Based upon reading of images by the surgeon, a virtual simulation of the surgical procedure is performed, allowing the surgical team to plan the placement of pedicle screws and navigate through safe pathways. The IGS system accommodates variations in the patient’s anatomy and surgical goals.

[0043] Subsequent to the pre-operative phase 102, the patient proceeds to the intra-operative phase 104. The patient is positioned on an operating table, and anaesthesia is administered. The surgical procedure extends into the intra-operative phase 104, where a seamless collaboration between the surgeon and a robotic system augments overall surgical capability. The surgical instruments are calibrated by tracking-fiducials to ensure real-time accuracy. The calibration is followed by attaching a dynamic reference base and guard for real-time tracking during surgery. The data collated during the pre-operative phase is transferred to the IGS system to execute the surgical plan. The IGS surgical system includes robotic arms positioned at precise positions over the patient to perform controlled and precise robotic arm movements. A C-arm calibrator, along with a tracking sensor, is placed at the appropriate position over the organ to perform the surgical procedure so that precise image registration 112 can take place. Theprecise image registration 112 ensures accurate real-time navigation during surgery. The image registration 112 acts as a connecting link between pre-operative planning 102 and intraoperative 104 procedure. The image registration 112 is achieved by employing techniques such as point-based registration and surface-based registration using a tracked stylus relying on anatomical features of the patient’s body. Further, in a minimally invasive surgical process, automatic fiducial-based registration may be employed for the image registration. Initially, intra-operative images are acquired by imaging devices such as a 2-Dimensional C-arm or 3- dimensional C-arm or CT-scan to gain insight into the organ of the patient’s body. These intraoperative images are superimposed with fiducial tracked jig for robust intra operative registration of the patient.

[0044] In one implementation, the IGS system is adaptable to different surgical scenarios, from straightforward fusions simple single anatomy to complex deformity corrections multianatomy surgeries. The choice of imaging modalities and registration methods is tailored to the specific requirements of each procedure. The robotic arms are integrated into the surgical process, providing controlled guidance to instruments. The robotic arms are synchronised with the navigation system's data, ensuring accuracy and reducing the margin of error.

[0045] Subsequent to image registration 112, the robotic arm-bearing surgical tools enters the patient’s body at the desired surface. During the intra-operative phase 104, real-time navigation of the surgical tools and implants plays a very important role in achieving precise and accurate surgery. The real-time tracking of the surgical tools is accomplished by the accompanying sensors and imaging devices placed over the desired body surface. A real time tracking feedback is provided to the operating surgeon so that any deviation of the surgical tool from the pre-defined path can be immediately rectified by the surgeon. Further, if there is a sudden change in the a sudden change in the condition of the organ during the intra-operative procedure, the surgeon can follow the navigation cues displayed on a screen to guide the surgical tool with precision.

[0046] Fig. 2 illustrates a hybrid-layered architecture 200 of the IGS system in accordance with an embodiment of the present invention. The IGS system comprises discrete and self- contained units such as a surgical unit, a navigation unit, a data processing unit and an interface unit. Each unit is configured to perform a specific task and separate responsibilities. These units work on a platform comprising of hybrid-layered architecture 200 to perform the desired surgical procedure based on a pre-defined surgical plan. The disclosed framework / architectureintegrates robotic system 204, navigation systems 202, and various imaging modalities for enhancing the IGS system’s efficiency, adaptability, and precision. The IGS system architecture is structured into four distinct layers, namely (i) Human Integration Layer 210 (ii) Hardware Integration Layer 220 (iii) Firmware Integration Layer 240 and (iv) Software Integration Layer 250.

[0047] The Human Integration Layer 210 comprises an output module and an Input module. During the surgical process, real-time feedback is provided to the user or operator 212. The real-time feedback can be in the form of 3 -dimensional live images over a display of the organ undergoing surgery or multiple data points provided by the sensors. The output module presents data to the user / operator 212 in a user-friendly form for further analysis. Based upon data received, the operator 212 confirms that the robotic surgical tool is following the path, as per the pre-operative plan and in case there is a deviation, the operator 212 imparts instructions to the robotic surgical arms through a multi-point touch screen arrangement. The Human Integration Layer 210 acts as an interface between the operator 212 and the IGS system and harmonizes and harmonises the surgical process. This layer captures multi-touch inputs and translates them into actionable commands.

[0048] The Human Integration Layer 210 transmits instructions to the robotic arm, imaging devices and sensors through a Hardware Integration Layer 220. The Hardware Integration Layer 220 coordinates the movement of the robotic arms along with the imaging devices 225 and the tracking sensors 228 based upon instructions received from the operator 212 during surgical processes. The imaging devices operating using different techniques, such as X-ray images, computer tomography (CT), magnetic resonance imaging (MRI) and / or positron emission tomography (PET), capture 3-dimensional images of the organ in real-time and transmit them to a display for visualisation by the operator 212. The surgical navigation system 202 provides real-time tracking data of the robotic surgical tool to the operator. Therefore, in order to locate the surgical tool precisely, a dynamic reference frame is provided with marking elements such as light-reflecting spherical markers to transmit the precise location of the surgical tool during a surgical procedure.

[0049] Further, a dynamic reference base and a dynamic reference guard 222 are attached to the patient and are constantly updated to track real-time patient movement with respect to the navigation system's spatial reference during the surgical procedures. The dynamic reference base 222 and dynamic reference guard 221 guide the precise positioning and stabilisation ofrobotic arms 230 so as to navigate surgical tools to execute the surgical plan accurately. The robotic arms 230 are further provided with end effectors 224 having sensors that are quickly replaceable during intra- surgical procedures. Robotic assistance provides real-time feedback, enhancing the surgeon's precision and dexterity. This synergistic interaction adapts dynamically to the surgeon's inputs, offering an intuitive and responsive surgical experience. The versatility of the disclosed system is a key feature, allowing adaptation to various image- guided surgical procedures, irrespective of the anatomical location of the affected organ in the patient’s body.

[0050] During the surgical procedures, a computation, processing and communication unit 227 (henceforth referred to as a CPC unit) analyses the data in real time from sensors and multiple devices. The data from the dynamic reference base 222, dynamic reference guard 221, tracked instruments 223, and end effectors 224 are transmitted to a master tracking sensor, which is further transmitted to the CPC Unit 227. The data from the imaging devices 225 and Display and touch interface 226 is also forwarded to the CPC Unit 227. The CPC unit 227 analyses data and transmits actionable commands to robotic arms and manipulator controllers 231 for end action leading to the surgical procedure. The surgical procedure is further supported by appropriate positioning and orientation of the robotic arms and manipulators 230, along with a floor stabilisation system to perform intricate surgical procedures.

[0051] A seamless interface is required between the operator’s intention and the resulting machine response for the proper functioning of the IGS system. The said interface is provided by a firmware integration layer 240 that acts as an intermediate connecting link transmitting commands from the operator 212, leading to precise hardware action. The display and touch firmware interpret touch gestures and coordinate with user interface software for seamless integration. The operating system firmware 240 manages hardware resources and facilitates communication between software layers. The robotic arm and manipulator firmware 246 govern robotic arm movements, translating commands into robotic actions.

[0052] The hardware features such as the surgical unit comprising robotic arms and manipulators 230, the navigation unit comprising imaging devices and sensors, the data processing unit 227 comprising a processor and a memory, the interface unit comprising an output module and input module function on an underlying software architecture referred as a software integration layer 250. The memory is configured to store programmes forimplementing various surgical procedures. These programs are alterable based on data provided by the imaging devices and the sensors.

[0053] The software integration layer 250 comprises of an image processing module 252, a navigation module 254 and a robotic control module 256. Said modules receive instructions from a main integration and data management module 262, which in turn draws information from a communication and networking module 258, a user visualisation and control interface module 260 and the computation and processing communication unit 227 via the operating system firmware 240.

[0054] The image processing module 252 manipulates images acquired by the imaging devices during pre-operative planning and intra-operative procedures through algorithms integrated with navigation and user visualisation modules. The multiple frames of images of an organ acquired by the imaging devices are used to prepare a 2D multiplanar reconstructed and / or 3D model of the organ. The 2D multiplanar reconstructed and / or 3D model models captured by the imaging devices are flipped and / or rotated as per the operator’s requirement. Further, the contrast and / or brightness of the affected area of the organ can be adjusted based on the requirement of the operator. The multi-scale pixel-level features of the organ are optimized optimised by anatomical segmentation and rendering so that the operator has a better understanding of the affected region of the organ to plan the surgical procedure.

[0055] The image processing module 252 further comprises an Iterative closet point (ICP) algorithm for image registration. This process of image registration establishes a relation between pre-operative images and intra-operative data. Further, different types of image registration processes, such as intensity-based registration and pose-based registration, are also employed to devise appropriate surgical planning and visualise surgical plans to be executed during planned surgery. The accuracy of image registration may further be enhanced by employing automated machine learning (Auto-ML) based surface registration. The image processing module 252 transfers data to the main integration and data management module 262, which interacts with the navigation module 254 to appropriately track the progress of the surgical tool with respect to the pre-planned surgical path.

[0056] The navigation module 254 employs the Iterative closest point (ICP) module by using fiducial markers. These fiducial markers play an important role in the optical tracking of the surgical tools during the surgical procedure. The IGS system is provided with the opticaltracker to determine the position of fiducials in the space around the organ of the patient where the surgical procedure is to be performed. The surgical tool is calibrated using a coordinate system to determine the position of tracking fiducials. During the surgical process, the optical tracker attached to the surgical tool measures the fiducials in the space where surgery is performed. The measured positions are registered to the calibrated position to determine the actual position of the surgical tool in space and, consequently, map the progress in real-time. The navigation module 254 integrates real-time tracking data, fiducial detection, surgical tool calibration, and tracking sensor data for patient image registration for precise instrument navigation. The data from the navigation module 254 is communicated to the main integration and data management module 262 and a robotic control module 256. Further, the IGS system allows to draw the intra-operative plan based on a plurality of artificial intelligence (Al) generated images dependent on data collected during the ICP registration. This further enhances the accuracy and precision of a particular surgical procedure.

[0057] The robotic control module 256 coordinates robotic arm movements, ensuring precise execution of surgical plans and real-time adjustments. The robotic arm's precision is driven by the amalgamation of inverse kinematics, trajectory planning, collision detection, and avoidance mechanisms, ensuring patient’s and user’s safety. The robotic control module 256 is integrated with the navigation module 254 and the image processing module 252 to perform the preplanned surgical procedure with the required precision and accuracy.

[0058] The IGS systems with a plurality of modules integrated by the hybrid-layered architecture 200 can be customised to accommodate different surgical specialties and preferences. The modular nature of hybrid-layered architecture 200 enables streamlined coordination between various modules. Alternative imaging modalities, such as MRI or CT, can be integrated, depending on specific surgical requirements. The modular nature of the IGS system allows us to integrate it with at least one of Augmented Reality (AR), Virtual Reality (VR), Mixed Reality (MR), and Extended Reality (XR) to achieve improved results. The modular and adaptable nature of the hybrid-layered architecture 200 provides a strong foundation for accommodating different Image-Guided Surgical Applications, such as orthopaedics, neurosurgery, pain management, biopsies, and ablations, promising to transform and elevate surgical practices across various medical disciplines.

[0059] Although a form of the invention has been described herein, it will be obvious to those skilled in the art that variations may be made in the construction and relation of parts andmethod without departing from the spirit and scope of the invention described herein. While embodiments of the present disclosure have been illustrated and described, it will be clear that the disclosure is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art without departing from the scope of the disclosure.

Claims

WE CLAIM:

1. An image-guided surgical system comprising: a surgical unit comprising one or more robotic arms 230 operating one or more surgical tools during a surgical procedure, with or without a pre-operative plan 102 and inputs of an operator 212, a navigation unit / system 202 comprising one or more sensors 228 and an imaging device 225 for tracking movement of the one or more surgical tools in real-time, during the surgical procedure, a computation, processing and communication unit (CPC) 227 unit comprising a processor configured to analyse data received from the one or more sensors 228 and the imaging device 225 to determine a degree of compliance with the pre-operative plan 102 and / or intra-operative plan 104 and guide further the operator 212 about progress of the one or more surgical tools, a memory configured to store program modules for controlling operation of the surgical unit, the navigation unit, the data processing unit, and an interface unit, the interface unit comprising an output module configured to provide data related to the movement of one or more surgical tools to the operator, an input module configured to receive input from the operator 212 in response to the data obtained from the output module, wherein the program modules are developed as a hybrid-layered architecture 200 and are alterable.

2. The image-guided surgical system, as claimed in claim 1, wherein the pre-operative plan 102 and / or intra-operative plan 104 is drawn based upon images acquired using the imaging device 225 and the program modules.

3. The image-guided surgical system, as claimed in claim 1, wherein the imaging device 225 operates using one of Computed Tomography (CT) scan, Magnetic resonance imaging(MRI) scan, Ultrasound, Positron Emission Tomography (PET), X-ray scan, and 2- Dimensional C-arm / O-arm imaging system during the pre-operative plan 102 and / or the surgical procedure.

4. The image-guided surgical system as claimed in claim 1, wherein the one or more sensors 228 and the imaging device 225 track movement of the one or more surgical tools with respect to the pre-operative plan 102, during the surgical procedure.

5. The image-guided surgical system as claimed in claim 2, wherein the images are used for representing 2D multiplanar reconstructed and / or 3D model of an organ to be operated during the surgical procedure.

6. The image-guided surgical system as claimed in claim 1, wherein the input module comprises one of a touch screen and a voice recognition device.

7. The image-guided surgical system as claimed in claim 1, wherein the image-guided surgical system is configured to integrate with at least one of Augmented Reality (AR), Virtual Reality (VR), Mixed Reality (MR), and Extended reality (XR).

8. The image-guided surgical system as claimed in claim 1, wherein the pre-operative plan 102 and / or intra-operative plan 104 is prepared by scanning an organ to be treated, by the imaging device using a plurality of fiducial markers.

9. The image-guided surgical system as claimed in claim 1, wherein an ICP (Iterative Closest Point) registration is performed by the data processing unit based on images obtained from the imaging device 225.

10. The image-guided surgical system as claimed in claim 1, wherein the intra-operative plan 102 can also drawn using a plurality of artificial intelligence (Al) generated images dependent on a data collected during the ICP registration.

11. The image-guided surgical system as claimed in claim 1, wherein the intra-operative plan 102 is alterable based upon input received from the navigation unit / system 202 during the surgical procedure.

12. The image-guided surgical (IGS) system as claimed in claim 1, wherein the IGS system is scaleable and adaptable to integration of new technologies.

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